NCT02128100

Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer

The Effect of FOLFIRINOX and Stereotactic Body Radiation Therapy for Locally Advanced, Non-Resectable Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.

Detailed description

The study will be a prospective, non-randomized, single center, trial to assess the effects of FOLIRINOX chemotherapy with SBRT on locally advanced, non-resectable pancreatic cancer. Patients will either undergo a biopsy to confirm the diagnosis or have strong clinical suspicion of a new cancer or recurrence based on the recommendations of a multi-disciplinary GI oncology team. FOLFIRINOX with be delivered prior to SBRT for 4 cycles. Restaging imaging will occur prior to SBRT delivery. SBRT will be delivered using standard stereotactic techniques to a dose of 3200cGy at 650cGy per fraction delivered over 2 weeks. Additional adjuvant chemotherapy with be delivered at the physician's discretion. Patients will be reassessed both clinically and radiographically at 3 months, 6 months, 9 months and 12 months post-treatment. Quality of life analysis will occur at 3 month intervals after treatment. Blood will be drawn for exploratory biomarker analysis at strategic timepoints during treatment and followup. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.

Conditions

• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
DRUG	Folfirinox	* Oxaliplatin 85 mg/m² for over 2 hours, * Leucovorin 400n mg/m² for over 2 hours, * Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion * Fluorouracil 400 mg/m² as a fast infusion over 15 minutes * Fluorouracil 2400 mg/m² as a slow infusion over 46 hours
RADIATION	Stereotactic Body Radiation Therapy	5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment.

Timeline

• Start date: 2014-09-19
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2014-05-01
• Last updated: 2024-03-05
• Results posted: 2024-03-05

Locations

1 site across 1 country: United States